drug
tucatinib
Marketedupdated 3mo agoby Seagen Inc
Approvedcommunity read0 votes
all catalysts(0)
nothing on the calendar yet
Trials studying tucatinib
- phase3A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
- phase3RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
- phase3T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
- phase2TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
- phase3A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer
- phase2Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
- phase3A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
- phase2Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Apr 17, 2027
245 days
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (14)
- Apr 27, 2038method-of-use (U-3783)US 11207324
- Apr 27, 2038method-of-use (U-3783)US 11207324
- Apr 27, 2038method-of-use (U-3783)US 11666572
- Apr 27, 2038method-of-use (U-3783)US 11666572
- Apr 27, 2038method-of-use (U-3783)US 12048698
- Apr 27, 2038method-of-use (U-3783)US 12048698
- Mar 25, 2033method-of-use (U-2788)US 11504370
- Mar 25, 2033method-of-use (U-2788)US 11504370
- Oct 12, 2032formulationUS 9457093
- Oct 12, 2032formulationUS 9457093
- Jan 14, 2031compositionUS 86480874.4y
- Jan 14, 2031compositionUS 86480874.4y
- May 9, 2027formulationUS 9693989267d
- May 9, 2027formulationUS 9693989267d
FDA exclusivities (6)
- Jan 19, 2030ODE-422Orphan Drug (7y)3.4y
- Jan 19, 2030ODE-422Orphan Drug (7y)3.4y
- Apr 17, 2027ODE-309Orphan Drug (7y)245d
- Apr 17, 2027ODE-309Orphan Drug (7y)245d
- Jan 19, 2026I-906Indication (3y)
- Jan 19, 2026I-906Indication (3y)
News(1)
- Post–T-DXd Sacituzumab Govitecan Plus Trastuzumab Yields Low ORR in HER2+ Metastatic Breast CancerSacituzumab govitecan plus trastuzumab following T-DXd did not meet the primary end point of the SATEEN trial in HER2+ metastatic breast cancer.onclive · 3mo ago
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